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YY/T 0855.1-2011: Test method and classification for the laser resistance of surgical drapes and/or patient protective covers. Part 1: Primary ignition and penetration
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Test method and classification for the laser resistance of surgical drapes and/or patient protective covers. Part 1: Primary ignition and penetration
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YY/T 0855.1-2011
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Basic data | Standard ID | YY/T 0855.1-2011 (YY/T0855.1-2011) | | Description (Translated English) | Test method and classification for the laser resistance of surgical drapes and/or patient protective covers. Part 1: Primary ignition and penetration | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 14,178 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | GB/T 15313-2008; ISO 11146-1 | | Adopted Standard | ISO 11801-1-2005, MOD | | Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard applies to the nominal resistance of laser and repetitive use of single-use surgical drapes and other protective coverings used in patients with non-woven material and woven materials. This section is a surgical drapes and other protective coverings patient harm caused by the laser provides a standard test and classification methods, and gives the corresponding classification system. This section does not include general fire safety norms. Similarly, this section includes neither other cause ignition sources, nor does it include laser-induced secondary ignition cover. All materials can be reflected part of the beam, the user must decide whether specular reflection may bring harm, but it does not involve in this section. | YY/T 0855.1-2011: Test method and classification for the laser resistance of surgical drapes and/or patient protective covers. Part 1: Primary ignition and penetration
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Test method and classification for the laser resistance of surgical drapes and/or patient protective covers.Part 1. Primary ignition and penetration
ICS 11.040.20
C48
People's Republic of China pharmaceutical industry standards
Surgical drapes and/or patient protective covers anti-laser
Test method and classification
Part 1. Primary ignition and penetration
patientprotectivecovers-Part 1. Primaryignitionandpenetration
(ISO 11801-1.2005, Lasersandlaser-relatedequipment-
Part 1. Primaryignitionandpenetration, MOD)
Issued on. 2013-06-01 2011-12-31 implementation
State Food and Drug Administration issued
Foreword
YY/T 0855 "surgical drapes and/or patient protective covers anti-laser test methods and classification" is divided into two parts.
--- Part 1. Primary ignition and penetration;
--- Part 2. Secondary ignition.
This section YY/T Section 10855 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
The partial modification of the use of ISO 11810-1.2005 "Lasers and laser-related equipment surgical drapes and/or patient protective covers anti-laser test
Test methods and classification - Part 1. Primary ignition and penetration. " The main changes are.
--- Of relevant terms by a footnote;
--- Modify the ISO 11810-1.2005 Table 1 error.
This part is proposed by the State Food and Drug Administration.
This part of the jurisdiction of the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
This part mainly drafted by. Shandong Hengxin detection technology development center.
The main drafters of this section. Ping Wu, Song Jinzai, Mupeng Tao.
Introduction
Certain medical surgical laser applications in laser surgery may require anti-mono- and/or other patient protective covering. In the sterile surgical too
Process, surgical drapes and/or other patient protective covering is necessary, while protecting the surrounding areas are not subject to liquid discharge and laser radiation accident
Shot effect. Conventional surgical drapes and/or other protective covering patients do not have to have anti-laser resistance, only dedicated only requires a single surgery
Laser anti-sex.
Laser-induced risks include, ignite, flammable, melting, penetration, heat transfer and reflection. Providing a laser barrier fabric and non-woven surgical
Single material may also have other risks. In the operating room often have more than one potential cause ignition device (for example. fiber optic lighting systems, electronic surgical device
Home, hot wire ignition device), this test method is only for laser-induced ignition source. YY/T 0855 for this part of the expected nominal single anti-laser surgery
And/or patient trial was covered. In addition, the area of this product may have different materials or design. According to the manufacturer's nominal or
End-user requirements, all nominal anti-laser areas may need to experiment.
CO2 laser offers the most challenging conditions for all medical laser. Burning/flammability test and the penetration test may find more
Challenging laser wavelengths and laser delivery models, Q- exchange such as within nanosecond range. YY/T 0855 this part of the selection 20W
CO2 laser (continuous wave) laser as a test.
Users of this test method should pay attention to, surgical drapes and/or other patient protective covering of anti-laser wavelength dependent, surgical drapes and /
Or other protective covering patient should be tested at a wavelength of intended use. If the experiment using other wavelengths, power setting and delivery team
Law, need to be explained.
YY /test results in this section T 0855 should not be used for other wavelengths and temporal patterns.
When used in combination than when used alone, a single anti-laser surgery patients or other protective covering performance might change.
Surgical drapes and/or patient protective covers anti-laser
Test method and classification
Part 1. Primary ignition and penetration
1 Scope
YY/T 0855 This section applies to a nominal one-time use of anti-laser and repetitive use of surgical drapes and other patient protective cover
It was the nonwoven and woven materials.
This section surgical drapes and other patient protective covering for the harm caused by the laser provides a standard test methods and classification, and
It gives the corresponding classification system. This section does not include a general fire safety specification. Also, this section includes neither caused by other sources of ignition, do not
Including laser-induced secondary ignition cover.
All materials will reflect a portion of the beam, the user must decide whether specular reflection may bring harm, but not in this section
It involved.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 15313-2008 laser terminology (ISO 11145.2006, MOD)
ISO 11146-1 Test methods for laser and laser-related equipment associated laser beam parameters - beam width, divergence angle and beam radiation factor
Part 1. no astigmatism and simple astigmatic beams (Lasersandlaser-relatedequipment-Testmethodsforlaserbeam
widths, divergenceanglesandbeam propagationratios-Part 1. Stigmaticandsimpleastigmatic
beams)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
I fired afterflame
Under test conditions, after the ignition source is removed continue burning material.
3.2
I burn time afterflametime
Under test conditions, the length of time after the ignition source is removed continue burning material.
3.3
Afterglow afterglow
Under test conditions, after cessation of flaming or after the ignition source is removed continue burning without emitting material occurs.
3.4
Afterglow time afterglowtime
Under test conditions, the material after cessation of flaming or after the ignition source is removed without combustion occurring duration of light emission length of time.
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